ACETAMINOPHEN

Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purposes
• ACETAMINOPHEN Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• ACETAMINOPHEN Other information
• Inactive ingredients
• Questions?
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FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

ACETAMINOPHEN Uses

• for the temporary relief of minor aches and pains due to:

•     headache
•     muscular aches
•     backache
•     minor pain of arthritis
•     the common cold
•     toothache
•     premenstrual and menstrual cramps
•     temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen 
• 3 or more alcoholic drinks every day while using this product
  

Do not use

• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.
  

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Do not take more than directed (see overdose warning)
  

Adults and children 12 years and over:

• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets in 24 hours unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
  

Children under 12 years: ask a doctor

ACETAMINOPHEN Other information

• Do not use if imprinted safety seal under cap is broken or missing.
  
• Store at room temperature
  

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact 1 800-medline.

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